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A multicenter, prospective, randomized, placebo-controlled, double-blind, multi-arm, multi-stage clinical trial of Ivabradine for heart Rate control In Septic shock [IRISS]
EU CTIS ID: 2024-515019-22-00
What this study is testing
The primary objective is to assess the efficacy of ivabradine in controlling heart rate and improving 28-day survival in patients with septic shock. These objectives will be assessed via a two-stage trial: activity (focused on heart rate control) and efficacy (focused on mortality).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older
- Proven or suspected site of infection
- Proven or suspected site of infection, - Septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure in the context of proven or suspected site of infection) for at least 2 hours and less than 24 hours (inclusion is possible before 2 hours in case of increasing doses of norepinephrine)
- In sinus rhythm with heart rate ≥ 95 bpm at time of randomization
- Informed consent obtained in accordance with local regulations
- Affiliation to a social security regime
You likely can't join if
- Cardiac arythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), sino-atrial block; 3rd degree atrioventricular block
- Severe chronic renal failure (creatinine clearance <15 ml/min) or hepatic failure (prothrombin time <20%)
- Enteral feeding impossible, vomiting, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption syndrome
- Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (<7 g/dL)
- Prior enrolment in the trial, participation in another interventional study on septic shock
- Known legal incapacity (patients under guardianship or curatorship)
See the full eligibility criteria
- 18 years of age or older
- Proven or suspected site of infection
- Proven or suspected site of infection, - Septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure in the context of proven or suspected site of infection) for at least 2 hours and less than 24 hours (inclusion is possible before 2 hours in case of increasing doses of norepinephrine)
- In sinus rhythm with heart rate ≥ 95 bpm at time of randomization
- Informed consent obtained in accordance with local regulations
- Affiliation to a social security regime
- Cardiac arythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), sino-atrial block; 3rd degree atrioventricular block
- Severe chronic renal failure (creatinine clearance <15 ml/min) or hepatic failure (prothrombin time <20%)
- Enteral feeding impossible, vomiting, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption syndrome
- Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (<7 g/dL)
- Prior enrolment in the trial, participation in another interventional study on septic shock
- Known legal incapacity (patients under guardianship or curatorship)
- Decision to limit full care taken before obtaining informed consent
- Patient under AME (state emergency medical help)
- Lack of affiliation to social security
- Cardiogenic shock or unstable or acute heart failure without proven or suspected infection
- Acute myocardial infarction with angiographic documentation; CCS class ≥ II angina pectoris;
- Septic shock requiring vasopressor treatment for more than 24 hours
- Refractory shock with systolic arterial pressure <90 mm Hg) despite the use of high doses of vasopressors (norepinephrine BASE or epinephrine BASE > 2.4 µg/kg/min; these doses should be multiplied by two for noradrenaline salt (tartrate or bitartrate)
- Co-treatment with drugs inducing bradycardia, QT lengthening or strong inhibition of CYP4503A4, pacemaker, defibrillator, kalemia <3 mM
- Co-treatment with verapamil or diltiazem (which are moderate CYP4503A4 inhibitors with heart rate reducing properties)
- Known pregnancy, breast feeding, women with childbearing potential will be tested for pregnancy and excluded if pregnant
- Known allergy to ivabradine or to any of the excipients, retinitis pigmentosa, congenital galactosemia, lactase deficiency, glucose or galactose malabsorption
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.